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Imaging and Physiology for Intermediate Left Main Stem Stenosis (VIP-LMS)

Primary Purpose

Coronary Artery Disease Left Main

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
iFR/ FFR/ IVUS/ OCT
Sponsored by
Instituto Dante Pazzanese de Cardiologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease Left Main focused on measuring Left Main Coronary Artery (LMCA), FFR, iFR, OCT, IVUS, intracoronary imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- age >/= 18 years;

  • patients who have an intermediate (40-70% diameter stenosis) lesion located in the LMS and a concomitant significant (>/=70% diameter stenosis) in one of the two major downstream vessels (the LAD or the LCx). The severity of LMS and downstream lesions will be assessed by visual estimation of the coronary angiography;

  • need of complementary diagnostic work up to ascertain the functional/physiological significance of the LMS lesion, that is not possible from the analysis of angiographic images only:

    • Intermediate severity of LMS lesion, or angiographic ambiguity;
    • Impossibility to conclusively associate the LMS lesion with the patient's symptoms/clinical presentation due to confounders introduced by the significant downstream lesion;
    • Impossibility to conclusively determine the severity and functional/physiological significance of the LMS lesion solely by the visual analysis of the coronary angiography;
    • Impossibility to conclusively determine the relative contribution of the LMS lesion to the ischemic burden determined by non-invasive functional tests due to the presence of a significant downstream lesion;

  • Clinical indication for PCI of the downstream lesion located in the LAD or LCx:

    • stable angina unresponsive to optimized medical treatment;
    • important ischemic burden (> 10% of myocardial mass in territories supplied by the diseased vessels);
    • Reduced FFR/iFR values indicative of myocardial ischemia with significant pressure gradient across the downstream lesion;
    • Acute coronary syndrome without ST elevation or stabilized (>7 days) acute myocardial infarction;
  • Downstream lesion anatomically suited for PCI;
  • LMS anatomy suited for PCI, with a low or intermediate SYNTAX score (< 32);
  • Lack of contra-indications for second-generation drug-eluting stents and/or use of dual antiplatelet therapy for at least 6 months.

Exclusion Criteria:

Left ventricular ejection fraction £ 40%;

  • Renal dysfunction with a glomerular filtration rate £ 45 mL/min;
  • Concomitance of right coronary artery occlusion supplied by collateral circulation from the left coronary;
  • Prior coronary artery bypass graft with at least on patent graft to any vessel of the left coronary;
  • Concomitant significant valvular heart disease;
  • The first 7 days of an acute myocardial infarction;
  • Downstream lesion located only in branches from the major downstream vessels (e.g. diagonal branches of LAD or obtuse marginal branches of the LCx);
  • Downstream lesions located in the distal segments of LAD or LCx;
  • Significant tortuosity of the downstream vessels in which difficulty to navigate with the physiology wire and/or intravascular imaging catheter is anticipated

Sites / Locations

  • Instituto Dante Pazzanese de CardiologiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intermediate LMS stenosis

Arm Description

Patients with intermediate left main stem stenosis with additional severe downstream lesion will be subject to physiology (FFR and iFR) at multiple sites along the target vessels before and after PCI of the severe lesion located in the downstream vessel. Intravascular imaging (IVUS and OCT) will be performed for additional evaluation of the left main stem stenosis.

Outcomes

Primary Outcome Measures

Change of iFR and FFR values of the LMS stenosis before and after PCI of the significant downstream stenosis
determine the change of iFR and FFR values of the LMS stenosis before and after PCI of the significant downstream stenosis (iFRtrue - iFRpred and FFRtrue - FFRpred)
Accuracy of intravascular imaging in predicting functionally signifcant LMS stenosis
establish the diagnostic accuracy of the minimum lumen areas determined by IVUS and OCT in the LMS in comparison with the iFRtrue and FFRtrue)

Secondary Outcome Measures

Accuracy of pressure changes in the iFR and FFR pullback curves before PCI of the downstream lesion in predicting the functional significance of LMS stenosis
Establish the accuracy of pressure changes in the iFR and FFR pullback curves before PCI of the downstream lesion to predict the iFRtue and FFRtrue observed after PCI of the downstream lesion;
Accuracy of iFRpred-contra and FFRpred-contra before PCI of the downstream lesion in predicting the functional significance of LMS stenosis
Establish the ability of iFRpred-contra and FFRpred-contra before PCI of the downstream lesion in predict the iFRtrue and FFRtrue of the LMS stenosis;
Agreement of the iFRcontra and FFRcontra after PCI of the downstream stenosis with the iFRtrue and FFRtrue.
Verify the agreement of the iFRcontra and FFRcontra after PCI of the downstream stenosis with the iFRtrue and FFRtrue.
Accuracy of minimum lumen area determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Diagnostic accuracy of the minimum lumen area in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Accuracy of minimum lumen diameter determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Diagnostic accuracy of the minimum lumen diameter in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Accuracy of percent diameter stenosis determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Diagnostic accuracy of the percent diameter stenosis in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Accuracy of percent area stenosis determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Diagnostic accuracy of the percent area stenosis in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Accuracy of lesion length determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Diagnostic accuracy of lesion length in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis

Full Information

First Posted
June 26, 2020
Last Updated
November 10, 2021
Sponsor
Instituto Dante Pazzanese de Cardiologia
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04531007
Brief Title
Imaging and Physiology for Intermediate Left Main Stem Stenosis
Acronym
VIP-LMS
Official Title
Validation of Intravascular Imaging and Physiology for Intermediate Left Main Stem Stenosis With Downstream Coronary Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Dante Pazzanese de Cardiologia
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present research aims to determine the impact of stenoses in downstream vessels on the FFR and iFR measurements of left main coronary artery (LMCA) stenoses of intermediate severity as determined by coronary angiography. Anatomic metrics derived from intravascular imaging modalities of IVUS and optical coherence tomography (OCT) will also be validated using as the comparator the FFRtrue and iFRtrue measurements pf LMCA lesions.
Detailed Description
Accurate characterization of the functional significance of intermediate stenoses located in the left main coronary artery (LMCA) is of central relevance for decisions about the need of myocardial revascularization. However, the physiological assessment of such lesions by means of fractional flow reserve (FFR) measurements are affected by stenoses in the downstream vessels (left anterior descending artery and/or left circumflex artery), which frequently coexist in series with LMCA lesions. More recently introduced, the instantaneous wave-free ratio (iFR) is a resting index that is less influenced by crosstalk between serial lesions and, in theory, could be more accurate for assessment of LMCA stenoses in the presence of downstream disease. Nonetheless, iFR has not been validated for assessment of LMCA lesions. Due to the difficulty in interpreting FFR results, the possibility of characterizing the atheroma type, precisely estimate lesion severity and disease extension and distribution, intravascular imaging [especially intravascular ultrasound (IVUS)] became an attractive alternative to assess LMCA lesions and guide the percutaneous treatment, whenever this strategy is selected. However, most IVUS validations for LMCA stenosis assessment used FFR as the standard comparator, which by itself has limited diagnostic ability in this anatomic scenario. Thus, the main objective of the current research project is to determine the impact of stenoses in downstream vessels on FFR and iFR measurements of LMCA stenoses of intermediate severity as determined by coronary angiography. The primary endpoint is the change (delta) in FFR and iFR values prior and after percutaneous treatment of downstream stenoses. Assuming a change of 0.04 mmHg between the FFRpredicted and FFRtrue with a standard deviation of 0.04 mmHg, and a change of 0.01 mmHg between iFRpredicted and iFRtrue with a standard deviation of 0.03 mmHg, a total of 53 patients are needed to confirm the mean difference of 0.03 mmHg between iFR and FFR changes before and after treatment of downstream stenoses. Anatomic metrics derived from intravascular imaging modalities of IVUS and optical coherence tomography (OCT) will also be validated using as the comparator the FFRtrue and iFRtrue measurements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease Left Main
Keywords
Left Main Coronary Artery (LMCA), FFR, iFR, OCT, IVUS, intracoronary imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermediate LMS stenosis
Arm Type
Experimental
Arm Description
Patients with intermediate left main stem stenosis with additional severe downstream lesion will be subject to physiology (FFR and iFR) at multiple sites along the target vessels before and after PCI of the severe lesion located in the downstream vessel. Intravascular imaging (IVUS and OCT) will be performed for additional evaluation of the left main stem stenosis.
Intervention Type
Diagnostic Test
Intervention Name(s)
iFR/ FFR/ IVUS/ OCT
Intervention Description
intermediate lesion evaluation with intracoronary physiology and imaging
Primary Outcome Measure Information:
Title
Change of iFR and FFR values of the LMS stenosis before and after PCI of the significant downstream stenosis
Description
determine the change of iFR and FFR values of the LMS stenosis before and after PCI of the significant downstream stenosis (iFRtrue - iFRpred and FFRtrue - FFRpred)
Time Frame
diagnostic procedure
Title
Accuracy of intravascular imaging in predicting functionally signifcant LMS stenosis
Description
establish the diagnostic accuracy of the minimum lumen areas determined by IVUS and OCT in the LMS in comparison with the iFRtrue and FFRtrue)
Time Frame
diagnostic procedure
Secondary Outcome Measure Information:
Title
Accuracy of pressure changes in the iFR and FFR pullback curves before PCI of the downstream lesion in predicting the functional significance of LMS stenosis
Description
Establish the accuracy of pressure changes in the iFR and FFR pullback curves before PCI of the downstream lesion to predict the iFRtue and FFRtrue observed after PCI of the downstream lesion;
Time Frame
diagnostic procedure
Title
Accuracy of iFRpred-contra and FFRpred-contra before PCI of the downstream lesion in predicting the functional significance of LMS stenosis
Description
Establish the ability of iFRpred-contra and FFRpred-contra before PCI of the downstream lesion in predict the iFRtrue and FFRtrue of the LMS stenosis;
Time Frame
diagnostic procedure
Title
Agreement of the iFRcontra and FFRcontra after PCI of the downstream stenosis with the iFRtrue and FFRtrue.
Description
Verify the agreement of the iFRcontra and FFRcontra after PCI of the downstream stenosis with the iFRtrue and FFRtrue.
Time Frame
diagnostic procedure
Title
Accuracy of minimum lumen area determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Description
Diagnostic accuracy of the minimum lumen area in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Time Frame
diagnostic procedure
Title
Accuracy of minimum lumen diameter determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Description
Diagnostic accuracy of the minimum lumen diameter in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Time Frame
diagnostic procedure
Title
Accuracy of percent diameter stenosis determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Description
Diagnostic accuracy of the percent diameter stenosis in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Time Frame
diagnostic procedure
Title
Accuracy of percent area stenosis determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Description
Diagnostic accuracy of the percent area stenosis in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Time Frame
diagnostic procedure
Title
Accuracy of lesion length determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Description
Diagnostic accuracy of lesion length in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Time Frame
diagnostic procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - age >/= 18 years; patients who have an intermediate (40-70% diameter stenosis) lesion located in the LMS and a concomitant significant (>/=70% diameter stenosis) in one of the two major downstream vessels (the LAD or the LCx). The severity of LMS and downstream lesions will be assessed by visual estimation of the coronary angiography; need of complementary diagnostic work up to ascertain the functional/physiological significance of the LMS lesion, that is not possible from the analysis of angiographic images only: Intermediate severity of LMS lesion, or angiographic ambiguity; Impossibility to conclusively associate the LMS lesion with the patient's symptoms/clinical presentation due to confounders introduced by the significant downstream lesion; Impossibility to conclusively determine the severity and functional/physiological significance of the LMS lesion solely by the visual analysis of the coronary angiography; Impossibility to conclusively determine the relative contribution of the LMS lesion to the ischemic burden determined by non-invasive functional tests due to the presence of a significant downstream lesion; Clinical indication for PCI of the downstream lesion located in the LAD or LCx: stable angina unresponsive to optimized medical treatment; important ischemic burden (> 10% of myocardial mass in territories supplied by the diseased vessels); Reduced FFR/iFR values indicative of myocardial ischemia with significant pressure gradient across the downstream lesion; Acute coronary syndrome without ST elevation or stabilized (>7 days) acute myocardial infarction; Downstream lesion anatomically suited for PCI; LMS anatomy suited for PCI, with a low or intermediate SYNTAX score (< 32); Lack of contra-indications for second-generation drug-eluting stents and/or use of dual antiplatelet therapy for at least 6 months. Exclusion Criteria: Left ventricular ejection fraction £ 40%; Renal dysfunction with a glomerular filtration rate £ 45 mL/min; Concomitance of right coronary artery occlusion supplied by collateral circulation from the left coronary; Prior coronary artery bypass graft with at least on patent graft to any vessel of the left coronary; Concomitant significant valvular heart disease; The first 7 days of an acute myocardial infarction; Downstream lesion located only in branches from the major downstream vessels (e.g. diagonal branches of LAD or obtuse marginal branches of the LCx); Downstream lesions located in the distal segments of LAD or LCx; Significant tortuosity of the downstream vessels in which difficulty to navigate with the physiology wire and/or intravascular imaging catheter is anticipated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Chamie, MD, PhD
Phone
+ 55 11 50856345
Email
daniel.chamie@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Chamie, MD, PhD
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fausto Feres, MD, PhD
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Chamie, MD, PhD
Phone
+ 55 11 50856345
Email
daniel.chamie@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Imaging and Physiology for Intermediate Left Main Stem Stenosis

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